从B细胞淋巴瘤-2抑制剂开发看国内外药企专利布局的异同

The similarities and differences in patent distribution of domestic and foreign pharmaceutical companies from the perspective of B-cell lymphoma-2 inhibitors

B细胞淋巴瘤-2(B-cell lymphoma-2,Bcl-2)在多种血液系统恶性肿瘤中呈不同程度的高表达,其具有明显抑制细胞凋亡的作用。目前,许多公司都在开发Bcl-2抑制剂以用于血液系统恶性肿瘤治疗,其中艾伯维公司的维奈克拉(venetoclax)已在多个国家或地区获准上市,亚盛医药的APG-2575和百济神州的BGB-11417则分别处于临床Ⅱ期和Ⅰ/Ⅱ期研究阶段。本文从专利申请的内容及途径、核心化合物专利申请的保护范围、联合用药3个角度,分析上述3家药企在Bcl-2抑制剂专利布局上的异同,希望对其他药企的药物和技术研发活动有所启迪。

B-cell lymphoma-2(Bcl-2)is highly expressed to varying degrees in various hematological malignancies,which has an obvious inhibitory effect on cell apoptosis.The target inhibitors corresponding to Bcl-2 have great potential in the treatment of anti-hematologic tumors.Many companies have been currently developing Bcl-2 inhibitors for the treatment of hematologic malignancies,with venetoclax from AbbVie approved in multiple countries or regions,and APG-2575 from Ascentage Pharma and BGB-11417 from Beigene in clinical PhaseⅡand PhaseⅠ/Ⅱ,respectively.This article analyzes the similarities and differences in the patent layout of Bcl-2 inhibitors of three pharmaceutical companies from three aspects,including content and way of patent application,protection scope of core compound patent and combined drug use,hoping to provide some inspirations for technology research and development and patent layout of domestic pharmaceutical companies.